BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCUTANEOUS SHEATH INTRODUCER KIT

    MDR report key: 2042696 · Received April 6, 2011

    Report

    Report Number
    2015691-2011-15155
    Event Type
    Malfunction
    Date Received
    April 6, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DQY
    PMA / PMN Number
    K831729
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF "THE BOTTOM OF THE SHEATH WAS BROKEN OFF DURING USE WITH A CCO CATHETER IN ICU" WAS CONFIRMED. WE RECEIVED ONE INTROFLEX 8.5F, A CONTAMINATION SHIELD AND CATHETER. AS RECEIVED THE INTRODUCER AND CONTAMINATION SHIELD WERE SEATED TO THE CATHETER (PROXIMAL END OF CONTAMINATION SHIELD WAS 108CM AND DISTAL END OF SHEATH WAS 37CM). THE CATHETER TIP WAS CUT AT THE 4CM AREA FROM THE TIP AS RECEIVED. THIS CONDITION WAS CONFIRMED THAT CATHETER TIP WAS CUT AT THE OUTSIDE OF THE PATIENT BODY. CENTRAL AREA OF THE SHEATH SOFT HUB WAS BROKEN OFF. VISUAL EXAMINATIONS WERE PERFORMED UNDER MICROSCOPE AT 10X MAGNIFICATION. CROSS SURFACES OF THE BROKEN SECTION DOES NOT APPEAR TO HAVE BEEN CUT. THE BROKEN SITE IS NOT CLEAN AND SMOOTH BUT APPEARED TO HAVE SLIGHTLY JAGGED EDGES. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    THE REPORT STATED THAT "THE BOTTOM OF THE SHEATH WAS BROKEN OFF DURING USE WITH A CCO CATHETER IN ICU". THE CUSTOMER COMMENTED THAT THE PATIENT TENDED TO BEND HIS/HER NECK AND SOME FORCE WAS APPLIED TO THE INSERTION SITE OF INTRODUCER. THEY RETURNED THE DEVICE FOR EVALUATION JUST IN CASE, ALTHOUGH "THEY DID NOT THINK THAT THIS EVENT WAS DEVICE RELATED". NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCUTANEOUS SHEATH INTRODUCER KIT STANDARD INTRODUCER DQY EDWARDS LIFESCIENCES, PR M095F85J UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1